The present invention relates to methods and compositions for monitoring, diagnosis, prognosis, and determination of treatment regimens in subjects suffering from or suspected of having a renal injury. In particular, the invention relates to using a one or more assays configured to detect a kidney injury marker selected from the group consisting of Thymic stromal lymphopoietin, Vascular endothelial growth factor receptor 1, CC motif chemokine 1, CC motif chemokine 17, CC motif chemokine 21, CC motif chemokine 27, FLT-3 Ligand, Immunoglobulin G subclass 3, Interleukin-1 receptor type I, Interleukin-20, Interleukin-29, Interleukin-7, Platelet-derived growth factor A/B dimer, Platelet-derived growth factor A/A dimer, and MMP9:TIMP2 complex as diagnostic and prognostic biomarkers in renal injuries.

Using expression of CC chemokine ligand (CCL24) to serve as an identification of a potential deriver of metastatic cancers and methods of detecting the presence of CCL24 to serve as a breast cancer diagnosis tool.

The present invention relates, in part, to certain serum biomarkers and use thereof in methods for treating cancer, such as in evaluating and/or in additional methods such as predicting patient responses to treatment with a CXCR4 inhibitor optionally in combination with a immunotherapeutic agent, in patients with a cancer such as melanoma, including resectable and unresectable melanoma.

A method for determining predisposition of a subject to developing renal dysfunction (AKI), and to a kit for use in making such a determination is provided. Suitably at least one marker selected from Midkine (MK) or H-FABP present in a blood or urine sample is used in the method.

Epileptic seizures are difficult to diagnose and are often difficult to distinguish from several conditions with similar presentations, and therefore, diagnosis of seizures is often a long, expensive, and unreliable process. This invention provides biomarkers for identifying seizures and epilepsy, assays for measuring and assessing biomarker concentration, predictive models based on biomarkers and computational systems for detecting, assessing and diagnosing phasic and tonic changes associated with seizures and epilepsy in all clinical and healthcare settings. Diagnostic and treatment methods, systems, kits, and predictive models provided herein, provide quantitative and/or qualitative assessment in order to allow patients to proceed immediately to diagnostic and/or treatment protocols, and assess therapeutic treatment effectiveness.

Provided are methods for assigning a subject having idiopathic multicentric Castleman disease (iMCD) to a group having a higher or lower probability of responding to treatment for iMCD using measured quantities of CXCL13. Also disclosed are methods of treating idiopathic multicentric Castleman disease (iMCD) in a subject in need thereof comprising administering to the subject an inhibitor of CXCL13 or of CXCR5. Also provided herein are methods for assigning a subject having idiopathic multicentric Castleman disease (iMCD) to a group having a higher or lower probability of responding to treatment for iMCD using measured quantities of specified biomarkers. The present disclosure also provides methods of treating idiopathic multicentric Castleman disease (iMCD) in a subject in need thereof comprising administering to the subject an inhibitor of the JAK-STAT3 pathway. Also disclosed are methods for assessing the absence or presence of iMCD in a subject.

The present disclosure is directed to novel biomarkers useful for staging EHV-1 infections and immunity status of horses. This disclosure is further directed to methods of determining EHV-1 infection stage and immunity status of horses using the novel biomarkers.

Provided are antibodies or fragments thereof having binding specificity to the human chemokine (C-X-C motif) ligand 13 (CXCL 13) protein. In various examples, the antibodies or fragments thereof include a VH and VL CDRs as disclosed herein, or variants thereof. Methods of using the antibodies or fragments thereof for treating autoimmune diseases and disorders are also provided.

The invention relates to a method for determining the presence of a tissue injury and repair (TIAR) process in the uterus of a subject. The presence of TIAR is employed as a marker for the presence of a preliminary stage and/or increased risk of developing a medical disorder associated with abnormal formation of endometrial tissue. Such medical conditions are preferably an archimetrosis, such as endometriosis or adenomyosis. The method comprises determining a level of CXCL12 and/or CXCR4 in a sample from a subject.

Provided are methods for diagnosing and predicting the outcome of a breast cancer patient or related cancers. The methods include determining expression levels of a plurality of biomarkers (selected genes) related to immune function in a biological sample, such as tumor tissues or a body fluid such as blood, from the patient. The expression levels of the biomarkers are used to derive an index which can be used as an indicator predictive of cancer patient outcome. Overexpression of a plurality of biomarkers of the invention can be used to generate a score or value which has been demonstrated herein to be indicative of a good or better patient outcome. The index, generated by the methods of the invention can also be used to stratify cancer subtypes, and also can be combined with conventional clinical parameters to better inform clinical decisions.